Plaintiff’s Expert Excluded a Second Time in California Nexium Litigation

doctors-Bal_Bhajanjit
Dr. Bhajanjit Sonny Bal, MD, JD, MBA, a Professor of Orthopaedic Surgery

Plaintiff’s expert witness Dr. Sonny Bal will not testify in litigation that Nexium causes bone fractures, according to a ruling by the California Court of Appeal. He had also been excluded in 2014 in simultaneous federal litigation involving Nexium by other plaintiffs.

However, Dr. Bal has been successfully admitted as a plaintiff’s expert witness in Zimmer NexGen Knee Implant Products Liability Litigation in federal court in Illinois (see below).

While he is an orthopedic surgeon specializing in hip and knee replacements, Dr. Bal lacked any special expertise in epidemiology and the metabolism of proton pump inhibitors (PPI) like Nexium, according to the California court. Jolena Wilson v. McKesson Corp, No. B266990, California Court of Appeal, Second Appellate District, Divison Three.

Summary judgment upheld

The ruling affirmed summary judgment for the defense in the case of 204 plaintiffs who sued AstraZeneca Pharmaceuticals and McKesson Corporations for negligence, fraud and products liability. The plaintiffs alleged that ingestion of Nexium causes bone deterioration, osteoporosis, or bone fractures.

Dr. Bal was the sole expert on causation for the plaintiffs. Dr. Bhajanjit Sonny Bal, MD, JD, MBA, is a Professor of Orthopaedic Surgery at the University of Missouri School of Medicine in Columbia, MO. He regularly treats bone fractures but does not have a specialty in epidemiology, bone biology, bone biology, endocrinology, gastroenterology, vitamin and mineral metabolism and how PPIs might compromise calcium intake.

“Dr. Bal never prescribed Nexium or any other PPIs, nor did he study the impact of PPIs on bones. Dr. Bal admitted he did not understand how proton pump inhibitors compromised calcium intake, and did not know how they were metabolized. When asked about the particulars regarding how PPIs could cause bone deterioration, Dr. Bal conceded at least 10 times that he would defer to “experts,” specifically a gastroenterologist, an epidemiologist, or an endocrinologist,” the court says.

“In short, Dr. Bal simply read epidemiological studies in preparation for this litigation and summarized what he thought such studies said.”

nexium-b-1Multidistrict litigation

Meanwhile,  plaintiffs who suffered kidney damage have filed a motion for the Judicial Panel on Multidistrict Litigation (JPML) to create a new MDL 2757 in Louisiana to consolidate dozens of lawsuits nationwide filed against manufacturers of PPI heartburn medicines.

They allege that as a result of ingesting a PPI for gastric acid-related conditions, they have been diagnosed with kidney injuries including acute interstitial nephritis (AIN), chronic kidney disease (CKD), and renal failure, also known as end-stage renal disease (ESRD).

Plaintiffs’ counsel have more than 5,000 Proton-Pump Inhibitor cases under investigation, with nearly 100 PPI cases will be filed in the coming weeks, according to plaintiff’s attorney Paul J. Pennock of Weitz & Luxenberg, P.C. in New York, NY.

Defendants include Takeda Pharmaceuticals USA, AstraZeneca Pharmaceuticals LP, Pfizer, Inc., and The Procter & Gamble Company. The products in question include Nexium, Prilosec, Protonix, Prevacid and Dexilant.

Zimmer Knee Implants

A federal judge overseeing the Zimmer NexGen Knee Implant Products Liability Litigation admitted Dr. Bal as a plaintiff’s causation expert whose opinion is that the company’s warning labels and instructions failed to warn adequately about the risk of failure for obese patients.

US District Judge Rebecca R. Pallmeyer rebuffed a defense motion under Rule 702 to exclude Dr. Bal in Beverly Goldin v. Zimmer Inc., Docket No. 11 C 5468.

There are 500 lawsuits filed against Zimmer in MDL No. 2272 in the Northern District of Illinois. Separately, Zimmer is facing 463 lawsuits in IN RE: Zimmer Durom Hip Cup Products Liability Litigation in MDL 2158 before U.S. District Judge Susan D. Wigenton in the District of New Jersey.

“Dr. Bal is sufficiently qualified to offer his opinions in this case and that those opinions are not so unreliable that the jury should not consider them,” the court said. “There are disputed issues of material fact concerning the adequacy of Defendant’s warnings and their role in causing Plaintiff’s injury. Those issues should be resolved by a jury.”

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Kidney Damage Plaintiffs Seek MDL for Proton Pump Inhibitor Lawsuits

nexium-b-1Six plaintiffs who suffered kidney damage have filed a motion for the Judicial Panel on Multidistrict Litigation (JPML) to create a new MDL 2757 in Louisiana to consolidate dozens of lawsuits nationwide filed against manufacturers of proton pump inhibitor (PPI) heartburn medicines.

The cases are among 15 actions  filed in federal court in California, Illinois, Kansas, Louisiana, Missouri, New Jersey, New York, Ohio, Tennessee, and West Virginia.

They allege that as a result of ingesting a PPI for gastric acid-related conditions, they have been diagnosed with kidney injuries including acute interstitial nephritis (AIN), chronic kidney disease (CKD), and renal failure, also known as end-stage renal disease (ESRD).

5,000 potential cases

Plaintiffs’ counsel have more than 5,000 Proton-Pump Inhibitor cases under investigation, with nearly 100 PPI cases will be filed in the coming weeks, according to plaintiff’s attorney Paul J. Pennock of Weitz & Luxenberg, P.C. in New York, NY.

Defendants include Takeda Pharmaceuticals USA, AstraZeneca Pharmaceuticals LP, Pfizer, Inc., and The Procter & Gamble Company. The products in question include Nexium, Prilosec, Protonix, Prevacid and Dexilant.

PPIs are a group of drugs containing Omeprazole that are intended to act as hydrogen potassium ATPase (“H+/K+ ATPase”) enzyme inhibitor to block the production of gastric acid. The FDA approved PPIs in 1989 and on Oct. 31, 2014 required PPIs to carry a warning label:

Acute interstitial nephritis has been observed in patients taking PPIs including [Brand]. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue [Brand] if acute interstitial nephritis develops.

The plaintiff’s brief cites several studied supporting their arguments:

  • In October 1992, researchers from the University of Arizona Health Sciences Center led by Stephen Ruffenach published the first article associating PPI usage with kidney injuries in The American Journal of Medicine.
  • In 2006, researchers at the Yale School of Medicine conducted a case series published in the International Society of Nephrology’s Kidney International finding that PPI use, by way of AIN, left most patients “with some level of chronic kidney disease.”
  • On August 23, 2011, Public Citizen, a consumer advocacy group, filed a petition with the FDA to add black box warnings and other safety information about several risks associated with PPIs including AIN.
  • In January 2016, a study published in the Journal of the American Medical Association found that PPI use was independently associated with a 20 – 50% higher risk of CKD.

Initial symptoms can be non-specific, such as fatigue, nausea and weakness. However, failure to treat interstitial nephritis (AIN) can lead to kidney death, dialysis, a kidney transplant or death.

The plaintiffs recommended the MDL be created in the federal Middle District of Louisiana in Baton Rouge before Chief Judge Brian A. Jackson, Judge Shelly D. Dick, Judge John W. deGravelles or Senior Judge James Joseph Brady. Alternatively, they would accepts venues including the District of New Jersey, Southern District of Illinois, the District of Kansas or the Western District of Louisiana.

 

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Judge Seeks Lead Counsel in Roundup Products Liability Litigation

roundup-cancerUS District Judge Vince Chhabria requested attorneys who wish to be lead counsel in In Re: Roundup Products Liability Litigation, MDL No. 2741, Case 3:16-md-02741-VC, to submit applications by October 20, when the first pretrial conference will be held in San Francisco.

The Judicial Panel on Multidistrict Litigation (JPML) created the new MDL in the Northern District of California. There are currently 21 actions pending in 14 districts. Including the potential tag-along actions, there are now 37 actions pending in 21 districts. More than 10 different law firms represent plaintiffs in these actions, which were spread across the country.

In the Oct. 6 order, Judge Chhabria stated that the parties will discuss:

  • The appointment of liaison and lead counsel for the plaintiffs.
  • The possibility of bifurcating proceedings to address general causation before any plaintiff-specific questions.
  • The schedule for discovery.
  • The merits of appointing an independent expert at the parties’ shared expense.

Causes cancer

The MDL Court noted that in the two actions previously pending in the Northern District of California, it had granted Monsanto’s request to bifurcate the proceedings. “However, because not all parties to the MDL have had an opportunity to be heard on this issue, the Court will consider additional arguments regarding bifurcation at the case management conference,” the judge wrote.

Three attorneys have submitted applications to be lead counsel including Robin Greenwald of Weitz & Luxenberg, Hunter Lundy of Lundy, Lundy, Soileau & South LLP, and Aimee H. Wagstaff of Andrus Wagstaff.

These lawsuits allege that Monsanto’s Roundup herbicide, particularly its active ingredient, glyphosate, causes non-Hodgkin’s lymphoma (cancer of the lymph nodes). Plaintiffs each allege that they or their decedents developed non-Hodgkin’s lymphoma after using Roundup over the course of several or more years. Plaintiffs also allege that the use of glyphosate in conjunction with other ingredients, in particular the surfactant polyethoxylated tallow amine (POEA), renders Roundup even more toxic than glyphosate on its own.

For more information read New Illinois Lawsuit Charges Monsanto’s Roundup Causes Cancer

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NJ Judge in Talc Cancer Case Bars Plaintiffs’ Experts, Dismisses Cases

talc johnson & johnsonNew Jersey Superior Court Judge Nelson C. Johnson barred two prominent scientists who were prepared to testify for  plaintiffs in product liability litigation charging that talc mined by Imerys and sold by Johnson & Johnson causes ovarian cancer.

J&J is facing 1,200 lawsuits in Missouri and New Jersey, charging it with failing to warn consumers about the cancer risks. Earlier this year juries in state court in St. Louis awarded 8-figure verdicts in trials charging that the company knew that its talc-based products cause ovarian cancer, and failed to warn women who used it.

In addition, the Judicial Panel on Multidistrict Litigation (JPML) created the new MDL 2738, In Re: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices and Products Liability Litigation, supervised by US District Judge Freda L. Wolfson in the District of New Jersey. There are 10 actions in 8 districts.

Grants summary judgment

Regardless, Judge Johnson ruled on Sept. 2 that Dr. Graham A. Colditz and Dr. Daniel W. Cramer were barred from testifying in multi-county litigation (MCL), and granted summary judgment for the defense in Brandi Carl v. Johnson & Johnson, Case No.: ATL-L-6546-14, and Diana Balderrama v. Johnson & Johnson, Case No.: ATL-L-6540-14.

The court seemed swayed by numbers, that Cramer and Colditz relied on case-control studies with a total of 18,384 participants while defense experts relied on cohort studies with 191,090 participants. Cohort studies compare the incidence of disease among individuals exposed to a substance with an unexposed group. Case-control studies examine the frequency of exposure in individuals who presently have the disease and compare them to a group of individuals who do not have the disease.

He criticized the scientists for presenting “made-for-litigation” testimony. “Plaintiffs’ experts fail to demonstrate ‘that the data or information used were soundly and reliably generated and are of a type reasonably relied upon by comparable experts,'” citing Rubanick v. Witco Chem. Corp., 125 NJ. 421, 432 (1991).

Graham A. Colditz, M.D., MPH, DRPH, FAFPHM, is the Chief of the Division of Public Health and Sciences in the Department of Surgery at Washington University School of Medicine. Dr. Colditz also serves as co-director of the Biostatistics Core for the Siteman Cancer Center. Dr. Colditz was presented on the issue of general causation of ovarian cancer.

Daniel W. Cramer, M.D., Sc.D., is a Professor of Obstetrics, Gynecology and Reproductive Biology at Brigham and Women’s Hospital, Harvard Medical School, and Professor of Epidemiology at the Harvard T.H. Chan School of Public Health. He heads the Research, Division of the OB-GYN Epidemiology Center. Dr. Cramer was presented on the issues of both general and specific causation of ovarian cancer.

Confused?

The judge waded into the details of cancer research and seemed confused between “ovarian cancer” and “invasive serious cancer,” the lack of inflammation in tissue that contained talc, which was surgically removed from each of the plaintiffs, and evidence about other gynecologic cancers of the vagina, cervix, uterus and fallopian tube (opinion page 20).

The judge flatly accepted the testimony of defense expert Lewis A. Chodosh that talc is inert, has anti-cancer properties, doesn’t cause death to normal cells, and doesn’t cause mutations.

The judge could not grasp the postulation of Cramer and Colditz that the talc flows upstream and lodges in the ovaries; it irritates cells in the ovaries, causes inflammation, which in turn causes immunosuppression, and causes cancer. ”

“Inflammation is an extremely complex issue and it is unclear whether chronic inflammation is sufficient to induce cancer in the absence of a carcinogen,” the judge wrote.

 

 

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Invokana Diabetes Drug Plaintiffs Seek Product Liability MDL in New Jersey

invokana-warning kidney-damageDozens of plaintiffs who suffered kidney damage or ketoacidosis have filed a motion to create new MDL 2750 for Invokana (Canagliflozin) Products Liability Litigation in federal court in New Jersey.

There are at least 56 actions pending in 11 different judicial districts against defendants Johnson & Johnson of New Brunswick, NJ, Janssen Pharmaceutical Inc. of Titusville, NJ (a J&J subsidiary) and Tanabe of Osaka, Japan.

The motion proposes that the Judicial Panel on Multidistrict Litigation (JPML) appoint Judge Brian R. Martinotti in the US District of New Jersey. He is already supervising 36 Invokana cases. The plaintiff’s attorneys are Christopher A. Seeger and Jeffrey Grand of Seeger Weiss in New York

Invokana went on sale in 2013 to treat type 2 diabetes by inhibiting renal glucose reabsorption with the goal of lowering blood glucose. Canagliflozin is a member of the gliflozin class of pharmaceuticals, also known as sodiumglucose cotransporter 2 (“SGLT2”) inhibitors.

Off label marketing

The defendants marketed and continue to market Invokana for off label purposes, including weight loss, reduced blood pressure, and improved glycemic control in type 1 diabetics.

In June 2016, the FDA released a safety announcement concerning canagliflozin and dapagliflozin, strengthening the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).

The FDA added a further warning for ketoacidosis, including “Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization have been identified in postmarketing surveillance in patients with type 1 and type 2 diabetes mellitus receiving sodium glucose cotransporter-2 (SGLT2) inhibitors, including INVOKANA.”

The FDA added even more warnings in August 2016. Also see: Health Canada Warns of Diabetic Ketoacidosis from Invokana Diabetes Drug

The federal court in New Jersey has been home to mass tort litigation involving the Zimmer Durom Hip Cup, Tropicana Orange Juice Marketing, Vytorin/Zetia Marketing, and Hypodermic Products Antitrust litigation.

Judge Martinotti was the mass tort judge in New Jersey state court in Bergen County from 2009 to 2016. In that position he supervised litigation involving Mirena Yaz, Yasmin, Ocella, and the DePuy ASR Hip Implant.

The motion will likely be heard at the JPML next meeting on Dec. 1.

 

 

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Crusading Judge Takes Over Taxotere Products Liability Litigation

Chief Judge Kurt Engelhardt
Chief Judge Kurt D. Engelhardt

Judge Kurt D. Engelhardt, who courageously investigated the New Orleans US Attorney’s Office for misconduct in a police murder prosecution, will apply his no-nonsense approach to dozens of mass tort lawsuits against Sanofi S.A. over its chemotherapy drug, Taxotere.

Judge Engelhardt, age 56, has been on the federal bench for 15 years and ascended to Chief Judge in the US Eastern District of Louisiana in New Orleans in 2015. Previously he has supervised two product liability MDLs:

  • Franck’s Lab. Inc. Product Liability Litigation MDL 2454, which was closed on May 21, 2016, when all the parties settled. The MDL was created in 2013. The lab compounded pharmaceutical products that were contaminated by fungus and toxins, which caused rare eye infections and blindness.
  • FEMA Trailer Products Liability Litigation MDL 1873, which was closed on October 26, 2015, after three waves of settlements. Companies that manufactured mobile homes for the Federal Emergency Management Agency after Hurricane Katrina agreed to pay $2.6 million to resolve claims that the mobile homes emitted formaldehyde

Engelhardt will supervise the new MDL No. 2740, In Re: Taxotere (Docetaxel) Products Liability Litigation consisting of 33 actions pending in 16 districts. The panel also has been notified of 56 related actions pending in 25 districts.

The plaintiffs charge that the Taxotere breast cancer drug causes unexpected, permanent and disfiguring hair loss in women. Although hair loss is a common temporary side effect of chemotherapy drugs, permanent alopecia is not. The lawsuits allege that Sanofi was aware of this possible side effect and failed to warn patients, and that the defendants marketed Taxotere as more effective than similar drugs when other drugs were equally effective without causing permanent hair loss.

“Grotesque Misconduct” in Federal Prosecution

A notorious criminal trial in New Orleans illustrates the importance that the judge places on the integrity of the courts. From 2012-2013 Judge Engelhardt investigated gross misconduct in the US Attorney’s office in New Orleans in its prosecution of five policemen who were charged in the 2005 killing of two people and injury of four others on the Danziger Bridge after Hurricane Katrina. The cops were convicted of civil rights and other charges in 2011.

The judge threw out the convictions in 2013 after determining that three federal prosecutors improperly attacked the judge, the police and defense lawyers in anonymous online postings, and leaked confidential information. Two investigations by the US Attorney’s office — one led by a guilty prosecutor — were cover-ups of “grotesque prosecutorial misconduct,” according to the judge.

“The public must have absolute trust and confidence in this process,” Engelhardt wrote in overturning the verdicts. “Re-trying this case is a very small price to pay in order to protect the validity of the verdict in this case, the institutional integrity of this court and the criminal justice system as a whole.”

The 5th Circuit upheld Judge Engelhardt’s decision in 2015, and the case finally ended on April 20, 2016, when the five Danziger Bridge cops pleaded guilty.

The Fifth Circuit ruled that the prosecutors’ “insidious” cyberbullying created a mob mentality against the defendants. “[p]rejudice here was shown both from this pattern of misconduct and evasion and from other abusive prosecutor actions,” it said. “A miscarriage of justice harms the substantial rights of a defendant, and it may consist of errors and omissions considered for their cumulative effect on the trial proceedings.”

Judge Engelhardt’s skepticism of the Department of Justice was also highlighted in the three-year sentence he imposed on a corrupt local prosecutor, St. Charles Parish District Attorney Harry Morel Jr. An FBI agent had sent the judge a 31-page letter about ethical lapses in the Justice Department. Engelhardt refused to release the letter but said it was “particularly interesting (and troubling, to say the least).”

The Justice department had ended an investigation into serious allegations that he traded leniency in court for sex from defendants, but let him plead guilty to obstruction of justice. Judge Engelhardt gave Morel the maximum sentence allowed.

Recently he sentenced once-fugitive real estate financier Robert Durst to 7 years and 1 month on a weapons charge that cleared the path for him to face murder charges in California. Durst will serve more than 4 ½ times the maximum under federal guidelines based on a plea deal with prosecutors in Houston, Manhattan and Orleans Parish not to prosecute him on a variety of offenses.

Cited for excellence

As an MDL judge, Engelhardt can be expected to be an efficient stickler for deadlines and details. In 2004 he was appointed by US Supreme Court Chief Justice Rehnquist to serve on the Judicial Conference Committee on Federal-State Jurisdiction, where he served two terms, which may be beneficial in the MDL case management. His work on the Judiciary Commission has been cited for its excellence by the Louisiana Supreme Court.

On the bench, had actually has few criminal case opinions. Most of his rulings focus on insurance coverage disputes, contract actions, legal malpractice and immigration.

In the 2,059 opinions that he’s written since 2002, Judge Engelhardt cites frequently to the 5th Circuit, and often relies on deposition and trial testimony to support his decisions. He writes matter-of-fact and direct opinions and doesn’t stray from the issues of the case.

In scheduling order dates, he does not permit waivers from the dates absent substantive notice to the court by timely motion.

In personal injury cases, he tends to rule in favor of summary judgment defendants where there is any question as to causation or future damages for injuries. In personal injury cases where remand is requested, prior settlement language as to co-defendants is strictly interpreted as to who remains in the case.

Prior to becoming a judge he handled commercial litigation disputes over contracts and insurance coverage disputes. He practiced at Hailey, McNamara, Hall, Larrman & Papale, an insurance defense firm in Metarie, LA. 

The Hailey firm does not appear to have been involved in representing any pharma or drug device clients, there is a brief reference to products liability defense work in the practice summary, but no cases listed to date.

 

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